[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600678":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":42,"centralContacts":43,"locations":53,"responsibleParty":68,"collaborators":42,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":42,"enrollmentInfo":81,"targetDuration":42,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":93,"overallStatus":55,"whyStopped":42,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"University of Palermo","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Clobetasol Patch","EXPERIMENTAL","Participants will receive a mucoadhesive patch containing clobetasol propionate 0.05%. The patch is applied directly to the symptomatic oral lesion once daily for 30 days, following oral hygiene. No food or drink is allowed for 30 minutes after application. The patch is self-dissolving.",[13],"Drug: Clobetasol Patch",{"label":15,"type":10,"description":16,"interventionNames":17},"Clobetasol + Resveratrol Patch","Participants will receive a mucoadhesive patch containing clobetasol propionate 0.05% and resveratrol. The patch is applied once daily for 30 days on the symptomatic oral lesion. It is self-adhering and dissolves without removal. No food or drink is allowed for 30 minutes after application.",[18],"Drug: Clobetasol + Resveratrol Patch",{"label":20,"type":21,"description":22,"interventionNames":23},"Clobetasol in Orabase","ACTIVE_COMPARATOR","Participants will receive clobetasol propionate 0.05% in an orabase-type adhesive paste, applied once daily for 30 days after oral hygiene. Application is made directly to the lesion. No food or drink is allowed for 30 minutes after application.",[24],"Drug: Clobetasol in Orabase",[26,32,37],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","A mucoadhesive patch containing clobetasol propionate 0.05%. Applied once daily for 30 days to the oral lesion.",[9],[31],"Mucoadhesive Clobetasol Patch",{"type":27,"name":15,"description":33,"armGroupLabels":34,"otherNames":35},"A mucoadhesive patch containing clobetasol propionate 0.05% and resveratrol. Applied once daily for 30 days to the oral lesion.",[15],[36],"Mucoadhesive Patch with Clobetasol and Resveratrol",{"type":27,"name":20,"description":38,"armGroupLabels":39,"otherNames":40},"Clobetasol propionate 0.05% in orabase-type adhesive paste. Applied once daily for 30 days to the oral lesion.",[20],[41],"Clobetasol 0.05% Orabase Paste",null,[44,49],{"name":45,"role":46,"phone":47,"phoneExt":42,"email":48},"Vera Panzarella","CONTACT","091 6554612","vera.panzarella@unipa.it",{"name":50,"role":46,"phone":51,"phoneExt":42,"email":52},"Viviana De Caro","09123891926","viviana.decaro@unipa.it",[54],{"facility":5,"status":55,"city":56,"state":57,"zip":42,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"RECRUITING","Palermo","Italy","IT",{"type":60,"coordinates":61},"Point",[62,63],13.3636,38.1166,{"lat":63,"lon":62},[66],{"name":5,"role":46,"phone":67,"phoneExt":42,"email":42},"091 238 93011",{"type":69,"investigatorFullName":45,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"PRINCIPAL_INVESTIGATOR","Associate Professor","100600678","phase-2-mucoadhesive-modified-release-formulations-for-the-topical-treatment-of-symptomatic-oral-lichen-planus-100600678",false,"NCT07100613","Mucoadhesive Modified-Release Formulations for the Topical Treatment of Symptomatic Oral Lichen Planus","Efficacy of a Microparticulate Muco-adhesive Patch Containing Drug-nutraceutical Association in paTIents Affected by Oral Mucosa Alterations (EMPATIA)","EMPATIA","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Clinical suspicion of Oral Lichen Planus (OLP).\n* Histological confirmation of OLP based on World Health Organization (WHO) criteria (presence of hyperkeratosis, acanthosis, basal cell degeneration, and a band-like lymphocytic infiltrate in the lamina propria).\n* Absence of epithelial dysplasia.\n* Ability to understand and sign informed consent.\n\nExclusion Criteria:\n\n* Previous diagnosis or treatment for OLP.\n* Use of topical or systemic corticosteroids in the last 4 weeks.\n* Use of medications known to cause lichenoid reactions.\n* History of allergic reactions to dental materials (e.g., amalgam).\n* Hematological disorders or immunodeficiencies.\n* Pregnancy or breastfeeding.\n* Current use of immunosuppressive therapies.\n* Inability or unwillingness to comply with study procedures.","ALL","18 Years",{"count":82,"type":83},45,"ESTIMATED","INTERVENTIONAL",[86],"PHASE2","The goal of this clinical trial is to learn if a mucoadhesive patch containing clobetasol alone or in combination with resveratrol can reduce symptoms and improve quality of life in adults with Oral Lichen Planus (OLP). The main questions it aims to answer are:\n\nDoes the patch reduce oral pain and burning sensations? Does it improve the appearance of oral lesions and patients' daily well-being?\n\nResearchers will compare:\n\nA patch containing clobetasol A patch containing clobetasol and resveratrol A standard clobetasol 0.05% ointment in an adhesive base\n\nParticipants will:\n\nApply their assigned treatment to the oral lesion daily for 30 days Attend three clinical visits for evaluations and imaging Complete questionnaires about pain, symptoms, and treatment experience",[89,90,91,92],"Oral Lichen Planus","Oral Lichen Planus Related Stress","Oral Mucosal Disease","Oral Pain",[94,95,96,97,98,99,100],"mucoadhesive patch","oral lichen planus","clobetasol","resveratrol","drug delivery system","Optical coherence tomography","Ora pain","2025-07-30",{"date":103,"type":104},"2025-08-03","ACTUAL",{"date":106,"type":104},"2024-09-04",{"date":108,"type":83},"2027-10-01",{"name":5,"class":6},1]